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FDA reopens National Forensic Chemistry Center after expansion and renovation

The U.S. Food and Drug Administration posted a photo:

U.S. Food and Drug Administration officials and General Services Administration leaders officially reopen the National Forensic Chemistry Center during a ribbon-cutting ceremony, Sept. 24, 2024, highlighting the completion of the 64,000-square-foot expansion and renovation of the center in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

(From left)
Marie Maguire, Assistant Special Agent in Charge, Headquarters Operations, Office of Criminal Investigations, FDA
James Sigg, Deputy Commissioner for Operations and Chief Operating Officer, Office of the Commissioner, FDA
Catherine Dasenbrock, Director, National Forensic Chemistry Center, Office of Inspections and Investigations (OII), FDA
Duane Satzger, Associate Director, Office of Medical Products and Specialty Laboratory Operations, OII, FDA
Katy Kale, Deputy Administrator, GSA
Douglas Stearn, Principal Deputy Associate Commissioner, OII, FDA

FDA photo by Matthew MacRoberts




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FDA reopens National Forensic Chemistry Center after expansion and renovation

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts




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FDA reopens National Forensic Chemistry Center after expansion and renovation

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts




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FDA reopens National Forensic Chemistry Center after expansion and renovation

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts




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Funding Cutbacks at FDA: A Sequester Primer

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Altogether, FDA will lose about $209 million between now and September 30, 2013. This will reduce inspections, slow drug and device approvals, and restrict implementation of the Food Safety Modernization Act and other recent legislation. Because of the many questions about the process and outcome, this is FDA Matters’ primer on the sequester of FDA funds.




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Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>




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Prime minister vows to reimburse community pharmacy's COVID-19 costs 'as soon as possible'

Community pharmacies should be reimbursed for their additional costs during the COVID-19 pandemic “as soon as possible”, the prime minister has told The Pharmaceutical Journal.




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Health boards say around half of pharmacies have expressed interest in providing COVID-19 vaccines

Around half of Wales’ community pharmacies have expressed interest to health boards in providing COVID-19 vaccinations as part of the national programme.




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Keeping It Simple: What Really Matters For Emerging Enterprises  

By Ankit Mahadevia, chairman of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC A common theme in startup literature is that by cutting a range of unnecessary tasks, a step-change in results will follow.  I’ve found

The post Keeping It Simple: What Really Matters For Emerging Enterprises   appeared first on LifeSciVC.




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Counterfeit Drugs in Clinical Trials?

This morning I ran across a bit of a coffee-spitter: in the middle of an otherwise opaquely underinformative press release fromTranscelerate Biopharma about the launch of their

Counterfeits flooding
the market? Really?
"Comparator Network" - which will perhaps streamline member companies' ability to obtain drugs from each other for clinical trials using active comparator arms -  the CEO of the consortium, Dalvir Gill, drops a rather remarkable quote:

"Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs.  With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial."

[Emphasis added.]

I have to admit to being a little floored by the idea that there is any sort of risk, in industry-run clinical trials, of counterfeit medication "infiltration".

Does Gill know something that the rest of us don't? Or is this just an awkward slap at perceived competition – innuendo against the companies that currently manage clinical trial comparator drug supply? Or an attempt at depicting the trials of non-Transcelerate members as risky and prone to fraud?

Either way, it could use some explaining. Thinking I might have missed something, I did do a quick literature search to see if I could come across any references to counterfeits in trials. Google Scholar and PubMed produced no useful results, but Wikipedia helpfully noted in its entry on counterfeit medications:

Counterfeit drugs have even been known to have been involved in clinical drug trials.[citation needed]


And on that point, I think we can agree: Citation needed. I hope the folks at Transcelerate will oblige.




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Can a Form Letter from FDA "Blow Your Mind"?

Adam Feuerstein appears to be a generally astute observer of the biotech scene. As a finance writer, he's accosted daily with egregiously hyped claims from small drug companies and their investors, and I think he tends to do an excellent job of spotting cases where breathless excitement is unaccompanied by substantive information.


However, Feuerstein's healthy skepticism seems to have abandoned him last year in the case of a biotech called Sarepta Therapeutics, who released some highly promising - but also incredibly limited - data on their treatment for Duchenne muscular dystrophy. After a disappointing interaction with the FDA, Sarepta's stock dropped, and Feuerstein appeared to realize that he'd lost some objectivity on the topic.


However, with the new year comes new optimism, and Feuerstein seems to be back to squinting hard at tea leaves - this time in the case of a form letter from the FDA.


He claims that the contents of the letter will "blow your mind". To him, the key passage is:


We understand that you feel that eteplirsen is highly effective, and may be confused by what you have read or heard about FDA's actions on eteplirsen. Unfortunately, the information reported in the press or discussed in blogs does not necessarily reflect FDA's position. FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular.


Feuerstein appears to think that the fact that FDA "has reached no conclusions" may mean that it may be "changing its mind". To which he adds: "Wow!"
Adam Feuerstein: This time,
too much froth, not enough coffee?


I'm not sure why he thinks that. As far as I can tell, the FDA will never reach a conclusion like this before its gone through the actual review process. After all, if FDA already knows the answer before the full review, what would the point of the review even be? It would seem a tremendous waste of agency resources. Not to mention how non-level the playing field would be if some companies were given early yes/no decisions while others had to go through a full review.


It seems fair to ask: is this a substantive change by FDA review teams, or would it be their standard response to any speculation about whether and how they would approve or reject a new drug submission? Can Feuerstein point to other cases where FDA has given a definitive yes or no on an application before the application was ever filed? I suspect not, but am open to seeing examples.


A more plausible theory for this letter is that the FDA is attempting a bit of damage control. It is not permitted to share anything specific it said or wrote to Sarepta about the drug, and has come under some serious criticism for “rejecting” Sarepta’s Accelerated Approval submission. The agency has been sensitive to the DMD community, even going so far as to have Janet Woodcock and Bob Temple meet with DMD parents and advocates last February. Sarepta has effectively positioned FDA as the reason for it’s delay in approval, but no letters have actually been published, so the conversation has been a bit one-sided. This letter appears to be an attempt at balancing perspectives a bit, although the FDA is still hamstrung by its restriction on relating any specific communications.

Ultimately, this is a form letter that contains no new information: FDA has reached no conclusions because FDA is not permitted to reach conclusions until it has completed a fair and thorough review, which won't happen until the drug is actually submitted for approval.

We talk about "transparency" in terms of releasing clinical trials data, but to me there is a great case to be made for increase regulatory transparency. The benefits to routine publication of most FDA correspondence and meeting results (including such things as Complete Response letters, explaining FDA's thinking when it rejects new applications) would actually go a long way towards improving public understanding of the drug review and approval process.




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Patient Centered Trials - Your Thoughts Needed

The good folks down at eyeforpharma have asked me to write a few blog posts in the run-up to their Patient Centered Clinical Trials conference in Boston this September. In my second article -Buzzword Innovation: The Patient Centricity “Fad” and the Token Patient - I went over some concerns I have regarding the sudden burst of enthusiasm for patient centricity in the clinical trial world.

Apparently, that hit a nerve – in an email, Ulrich Neumann tells me that “your last post elicited quite a few responses in my inbox (varied, some denouncing it as a fad, others strongly protesting the notion, hailing it as the future).”

In preparing my follow up post, I’ve spoken to a couple people on the leading edge of patient engagement:


In addition to their thoughts, eyeforpharma is keenly interested in hearing from more people. They've even posted a survey – from Ulrich:
To get a better idea of what other folks think of the idea, I am sending out a little ad hoc survey. Only 4 questions (so people hopefully do it). Added benefit: There is a massive 50% one-time discount for completed surveys until Friday connected to it as an incentive).
So, here are two things for you to do:

  1. Complete the survey and share your thoughts
  2. Come to the conference and tell us all exactly what you think

Look forward to seeing you there.

[Conflict of Interest Disclosure: I am attending the Patient Centered Clinical Trials conference. Having everyone saying the same thing at such conferences conflicts with my ability to find them interesting.]





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Will Your Family Make You a Better Trial Participant?

It is becoming increasing accepted within the research community that patient engagement leads to a host of positive outcomes – most importantly (at least practically speaking) improved clinical trial recruitment and retention.

But while we can all agree that "patient engagement is good" in a highly general sense, we don't have much consensus on what the implications of that idea might be. There is precious little hard evidence about how to either attract engaged patients, or how we might effectively turn "regular patients" into "engaged patients".

That latter point - that we could improve trial enrollment and completion rates by converting the (very large) pool of less-engaged patient - is a central tenet of the mHealth movement in clinical trials. Since technology can now accompany us almost anywhere, it would seem that we have an unprecedented opportunity to reach out and connect with current and potential trial participants.

However, there are signs that this promised revolution in patient engagement hasn't come about. From the decline of new apps being downloaded to the startlingly high rate of people abandoning their wearable health devices, there's a growing body of evidence suggesting that we aren't in fact making very good progress towards increasing engagement. We appear to have underestimated the inertia of the disengaged patient.

So what can we do? We know people like their technology, but if they're not using it to engage with their healthcare decisions, we're no better off as a result.

Daniel Calvert, in a recent blog post at Parallel 6 offers an intriguing solution: he suggests we go beyond the patient and engage their wider group of loved ones. By engaging what Calvert calls the Support Circle - those people most likely to "encourage the health and well being of that patient as they undergo a difficult period of their life" - trial teams will find themselves with a more supported, and therefore more engaged, participant, with corresponding benefits to enrollment and retention. 

Calvert outlines a number of potential mechanisms to get spouses, children, and other loved ones involved in the trial process:
During the consent process the patient can invite their support team in with them. A mobile application can be put on their phones enabling encouraging messages, emails, and texts to be sent. Loved ones can see if their companion or family member did indeed take today’s medication or make last Monday’s appointment. Gamification offers badges or pop-ups: “Two months of consecutive appointments attended” or “perfect eDiary log!” Loved ones can see those notifications, like/comment, and constantly encourage the patients. 
Supporting materials can also be included in the Support Circle application. There are a host of unknown terms to patients and their team. Glossaries, videos, FAQs, contact now, and so much more can be made available at their fingertips.
I have to admit I'm fascinated by Calvert's idea. I want him to be right: the picture of supportive, encouraging, loving spouses and children standing by to help a patient get through a clinical trial is an attractive one. So is the idea that they're just waiting for us to include them - all we need to do is a bit of digital communication with them to get them fully on board as members of the study team.

The problem, however, remains: we have absolutely no evidence that this approach will work. There is no data showing that it is superior to other approaches to engage trial patients.

(In fact, we may even have some indirect evidence that it may hinder enrollment: in trials that require active caregiver participation, such as those in Alzheimer's Disease, caregivers are believed to often contribute to the barriers to patient enrollment).

Calvert's idea is a good one, and it's worthy of consideration. More importantly, it's worthy of being rigorously tested against other recruitment and retention approaches. We have a lot of cool new technologies, and even more great ideas - we're not lacking for those. What we're lacking is hard data showing us how these things perform. What we especially need is comparative data showing how new tactics work relative to other approaches.

Over 5 years ago, I wrote a blog post bemoaning the sloppy approaches we take in trial recruitment - a fact made all the more painfully ironic by the massive intellectual rigor of the trials themselves. I'm not at all sure that we've made any real progress in those 5 years.

In my next post, I'll outline what I believe are some of the critical steps we need to take to improve the current situation, and start bringing some solid evidence to the table along with our ideas.

[Photo credit: Flikr user Matthew G, "Love (of technology)"]







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Hospitals face months of IV fluid shortages after Helene damages N.C. factory

Hospitals have been forced to innovate with new ways of hydrating patients and giving them medications, after a key factory that produces IV fluid bags flooded during Hurricane Helene. (This story first aired on Morning Edition on Nov. 7, 2024.)




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What does a 2nd Trump term mean for the Affordable Care Act?

President-elect Donald Trump tried unsuccessfully to get rid of the Affordable Care Act during his first term. What action will he take this time around?




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More young people are surviving cancer. Then they face a life altered by it

More people are getting cancer in their 20s, 30s, and 40s, and surviving, thanks to rapid advancement in care. Many will have decades of life ahead of them, which means they face greater and more complex challenges in survivorship. Lourdes Monje is navigating these waters at age 29.




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Kumpulan Game Slot Gacor Dengan Persentase RTP Tertinggi Hari Ini

Dalam dunia perjudian online yang terus berkembang, pencarian para pemain untuk menemukan peluang terbaik dalam meraih kemenangan mengarah pada fenomena populer: kumpulan game slot gacor dengan persentase RTP tertinggi hari…

The post Kumpulan Game Slot Gacor Dengan Persentase RTP Tertinggi Hari Ini appeared first on Biosimilarnews.




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Nama-Nama Provider Slot Online Terbaik 2024

Industri slot online terus mekar dan mengukir epik baru dalam dunia judi online. Tahun 2024 menjadi saksi bagi loncatan tinggi dalam inovasi dan hiburan, terutama dari para provider terkemuka yang…

The post Nama-Nama Provider Slot Online Terbaik 2024 appeared first on Biosimilarnews.




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Provider Judi Slot Gacor Online Terbaik serta Populer di Tahun 2024

Seolah-olah melintasi portal waktu, kita memasuki tahun 2024 dengan deretan provider judi slot online yang tidak hanya menemani, tetapi juga menggoda imajinasi. Setiap klik, setiap putaran gulungan, membuka lembaran baru…

The post Provider Judi Slot Gacor Online Terbaik serta Populer di Tahun 2024 appeared first on Biosimilarnews.




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Link Daftar Situs Slot Gacor Gampang Menang Maxwin Terpercaya Hari Ini

Keuntungan besar dan kegembiraan yang ditawarkan oleh mesin slot online membuatnya semakin populer. Namun, dalam lautan situs slot yang ada, bagaimana Anda bisa menemukan situs slot terbaik yang dapat memberikan…

The post Link Daftar Situs Slot Gacor Gampang Menang Maxwin Terpercaya Hari Ini appeared first on Biosimilarnews.




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“Snake-like” Probe Images Arteries from Within



Neurosurgeon Vitor Mendes Pereira has grown accustomed to treating brain aneurysms with only blurry images for guidance.

Equipped with a rough picture of the labyrinthine network of arteries in the brain, he does his best to insert mesh stents or coils of platinum wire—interventions intended to promote clotting and to seal off a bulging blood vessel.

The results are not always perfect. Without a precise window into the arterial architecture at the aneurysm site, Pereira says that he and other neurovascular specialists occasionally misplace these implants, leaving patients at a heightened risk of stroke, clotting, inflammation, and life-threatening ruptures. But a new fiber-optic imaging probe offers hope for improved outcomes.

Pereira et al./Science Translational Medicine

According to Pereira’s early clinical experience, the technology—a tiny snake-like device that winds its way through the intricate maze of brain arteries and, using spirals of light, captures high-resolution images from the inside-out—provides an unprecedented level of structural detail that enhances the ability of clinicians to troubleshoot implant placement and better manage disease complications.

“We can see a lot more information that was not accessible before,” says Pereira, director of endovascular research and innovation at St. Michael’s Hospital in Toronto. “This is, for us, an incredible step forward.”

And not just for brain aneurysms. In a report published today in Science Translational Medicine, Pereira and his colleagues describe their first-in-human experience using the platform to guide treatment for 32 people with strokes, artery hardening, and various other conditions arising from aberrant blood vessels in the brain.

Whereas before, with technologies such as CT scans, MRIs, ultrasounds, and x-rays, clinicians had a satellite-like view of the brain’s vascular network, now they have a Google Street View-like perspective, complete with in-depth views of artery walls, plaques, immune cell aggregates, implanted device positions, and more.

“The amount of detail you could get you would never ever see with any other imaging modality,” says Adnan Siddiqui, a neurosurgeon at the University at Buffalo, who was not involved in the research. “This technology holds promise to be able to really transform the way we evaluate success or failure of our procedures, as well as to diagnose complications before they occur.”

A Decade of Innovation

The new fiber-optic probe is flexible enough to snake through the body’s arteries and provide previously unavailable information to surgeons.Pereira et al./Science Translational Medicine

The new imaging platform is the brainchild of Giovanni Ughi, a biomedical engineer at the University of Massachusetts’ Chan Medical School in Worcester. About a decade ago, he set out to adapt a technique called optical coherence tomography (OCT) for imaging inside the brain’s arteries.

OCT relies on the backscattering of near-infrared light to create cross-sectional images with micrometer-scale spatial resolution. Although OCT had long been used in clinical settings to generate pictures from the back of the eye and from inside the arteries that supply blood to the heart, the technology had proven difficult to adapt for brain applications owing to several technical challenges.

One major challenge is that the fiber-optic probes used in the technology are typically quite stiff, making them too rigid to twist and bend through the convoluted passageways of the brain’s vasculature. Additionally, the torque cables—traditionally used to rotate the OCT lens to image surrounding vessels and devices in three dimensions as the probe retracts—were too large to fit inside the catheters that are telescopically advanced into the brain’s arteries to address blockages or other vascular issues.

“We had to invent a new technology,” Ughi explains. “Our probe had to be very, very flexible, but also very, very small to be compatible with the clinical workflow.”

To achieve these design criteria, Ughi and his colleagues altered the properties of the glass at the heart of their fiber-optic cables, devised a new system of rotational control that does away with torque cables, miniaturized the imaging lens, and made a number of other engineering innovations.

The end result: a slender probe, about the size of a fine wire, that spins 250 times per second, snapping images as it glides back through the blood vessel. Researchers flush out blood cells with a tablespoon of liquid, then manually or automatically retract the probe, revealing a section of the artery about the length of a lip balm tube.

St. Michael’s Foundation

Clinical Confirmation

After initial testing in rabbits, dogs, pigs, and human cadavers, Ughi’s team sent the device to two clinical groups: Pereira’s in Toronto and Pedro Lylyk’s at the Sagrada Familia Clinic in Buenos Aires, Argentina. Across the two groups, neurosurgeons treated the 32 participants in the latest study, snaking the imaging probe through the patients’ groins or wrists and into their brains.

The procedure was safe and well-tolerated across different anatomies, underlying disease conditions, and the complexity of prior interventions. Moreover, the information provided frequently led to actionable insights—in one case, prompting clinicians to prescribe anti-platelet drugs when hidden clots were discovered; in another, aiding in the proper placement of stents that were not flush against the arterial wall.

“We were successful in every single case,” Ughi says. “So, this was a huge confirmation that the technology is ready to move forward.”

“We can see a lot more information that was not accessible before.” —Vitor Mendes Pereira, St. Michael’s Hospital

A startup called Spryte Medical aims to do just that. According to founder and CEO David Kolstad, the company is in discussions with regulatory authorities in Europe, Japan, and the United States to determine the steps necessary to bring the imaging probe to market.

At the same time, Spryte—with Ughi as senior director of advanced development and software engineering—is working on machine learning software to automate the image analysis process, thus simplifying diagnostics and treatment planning for clinicians.

Bolstered by the latest data, cerebrovascular specialists like Siddiqui now say they are chomping at the bit to get their hands on the imaging probe once it clears regulatory approval.

“I’m really impressed,” Siddiqui says. “This is a tool that many of us who do these procedures wish they had.”




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Is AI Search a Medical Misinformation Disaster?



Last month when Google introduced its new AI search tool, called AI Overviews, the company seemed confident that it had tested the tool sufficiently, noting in the announcement that “people have already used AI Overviews billions of times through our experiment in Search Labs.” The tool doesn’t just return links to Web pages, as in a typical Google search, but returns an answer that it has generated based on various sources, which it links to below the answer. But immediately after the launch users began posting examples of extremely wrong answers, including a pizza recipe that included glue and the interesting fact that a dog has played in the NBA.

Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory.

While the pizza recipe is unlikely to convince anyone to squeeze on the Elmer’s, not all of AI Overview’s extremely wrong answers are so obvious—and some have the potential to be quite harmful. Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory and has a new book out about the online propagandists who “turn lies into reality.” She has studied the spread of medical misinformation via social media, so IEEE Spectrum spoke to her about whether AI search is likely to bring an onslaught of erroneous medical advice to unwary users.

I know you’ve been tracking disinformation on the Web for many years. Do you expect the introduction of AI-augmented search tools like Google’s AI Overviews to make the situation worse or better?

Renée DiResta: It’s a really interesting question. There are a couple of policies that Google has had in place for a long time that appear to be in tension with what’s coming out of AI-generated search. That’s made me feel like part of this is Google trying to keep up with where the market has gone. There’s been an incredible acceleration in the release of generative AI tools, and we are seeing Big Tech incumbents trying to make sure that they stay competitive. I think that’s one of the things that’s happening here.

We have long known that hallucinations are a thing that happens with large language models. That’s not new. It’s the deployment of them in a search capacity that I think has been rushed and ill-considered because people expect search engines to give them authoritative information. That’s the expectation you have on search, whereas you might not have that expectation on social media.

There are plenty of examples of comically poor results from AI search, things like how many rocks we should eat per day [a response that was drawn for an Onion article]. But I’m wondering if we should be worried about more serious medical misinformation. I came across one blog post about Google’s AI Overviews responses about stem-cell treatments. The problem there seemed to be that the AI search tool was sourcing its answers from disreputable clinics that were offering unproven treatments. Have you seen other examples of that kind of thing?

DiResta: I have. It’s returning information synthesized from the data that it’s trained on. The problem is that it does not seem to be adhering to the same standards that have long gone into how Google thinks about returning search results for health information. So what I mean by that is Google has, for upwards of 10 years at this point, had a search policy called Your Money or Your Life. Are you familiar with that?

I don’t think so.

DiResta: Your Money or Your Life acknowledges that for queries related to finance and health, Google has a responsibility to hold search results to a very high standard of care, and it’s paramount to get the information correct. People are coming to Google with sensitive questions and they’re looking for information to make materially impactful decisions about their lives. They’re not there for entertainment when they’re asking a question about how to respond to a new cancer diagnosis, for example, or what sort of retirement plan they should be subscribing to. So you don’t want content farms and random Reddit posts and garbage to be the results that are returned. You want to have reputable search results.

That framework of Your Money or Your Life has informed Google’s work on these high-stakes topics for quite some time. And that’s why I think it’s disturbing for people to see the AI-generated search results regurgitating clearly wrong health information from low-quality sites that perhaps happened to be in the training data.

So it seems like AI overviews is not following that same policy—or that’s what it appears like from the outside?

DiResta: That’s how it appears from the outside. I don’t know how they’re thinking about it internally. But those screenshots you’re seeing—a lot of these instances are being traced back to an isolated social media post or a clinic that’s disreputable but exists—are out there on the Internet. It’s not simply making things up. But it’s also not returning what we would consider to be a high-quality result in formulating its response.

I saw that Google responded to some of the problems with a blog post saying that it is aware of these poor results and it’s trying to make improvements. And I can read you the one bullet point that addressed health. It said, “For topics like news and health, we already have strong guardrails in place. In the case of health, we launched additional triggering refinements to enhance our quality protections.” Do you know what that means?

DiResta: That blog posts is an explanation that [AI Overviews] isn’t simply hallucinating—the fact that it’s pointing to URLs is supposed to be a guardrail because that enables the user to go and follow the result to its source. This is a good thing. They should be including those sources for transparency and so that outsiders can review them. However, it is also a fair bit of onus to put on the audience, given the trust that Google has built up over time by returning high-quality results in its health information search rankings.

I know one topic that you’ve tracked over the years has been disinformation about vaccine safety. Have you seen any evidence of that kind of disinformation making its way into AI search?

DiResta: I haven’t, though I imagine outside research teams are now testing results to see what appears. Vaccines have been so much a focus of the conversation around health misinformation for quite some time, I imagine that Google has had people looking specifically at that topic in internal reviews, whereas some of these other topics might be less in the forefront of the minds of the quality teams that are tasked with checking if there are bad results being returned.

What do you think Google’s next moves should be to prevent medical misinformation in AI search?

DiResta: Google has a perfectly good policy to pursue. Your Money or Your Life is a solid ethical guideline to incorporate into this manifestation of the future of search. So it’s not that I think there’s a new and novel ethical grounding that needs to happen. I think it’s more ensuring that the ethical grounding that exists remains foundational to the new AI search tools.




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Biocompatible Mic Could Lead to Better Cochlear Implants



Cochlear implants—the neural prosthetic cousins of standard hearing aids—can be a tremendous boon for people with profound hearing loss. But many would-be users are turned off by the device’s cumbersome external hardware, which must be worn to process signals passing through the implant. So researchers have been working to make a cochlear implant that sits entirely inside the ear, to restore speech and sound perception without the lifestyle restrictions imposed by current devices.

A new biocompatible microphone offers a bridge to such fully internal cochlear implants. About the size of a grain of rice, the microphone is made from a flexible piezoelectric material that directly measures the sound-induced motion of the eardrum. The tiny microphone’s sensitivity matches that of today’s best external hearing aids.

Cochlear implants create a novel pathway for sounds to reach the brain. An external microphone and processor, worn behind the ear or on the scalp, collect and translate incoming sounds into electrical signals, which get transmitted to an electrode that’s surgically implanted in the cochlea, deep within the inner ear. There, the electrical signals directly stimulate the auditory nerve, sending information to the brain to interpret as sound.

But, says Hideko Heidi Nakajima, an associate professor of otolaryngology at Harvard Medical School and Massachusetts Eye and Ear, “people don’t like the external hardware.” They can’t wear it while sleeping, or while swimming or doing many other forms of exercise, and so many potential candidates forgo the device altogether. What’s more, incoming sound goes directly into the microphone and bypasses the outer ear, which would otherwise perform the key functions of amplifying sound and filtering noise. “Now the big idea is instead to get everything—processor, battery, microphone—inside the ear,” says Nakajima. But even in clinical trials of fully internal designs, the microphone’s sensitivity—or lack thereof—has remained a roadblock.

Nakajima, along with colleagues from MIT, Harvard, and Columbia University, fabricated a cantilever microphone that senses the motion of a bone attached behind the eardrum called the umbo. Sound entering the ear canal causes the umbo to vibrate unidirectionally, with a displacement 10 times as great as other nearby bones. The tip of the “UmboMic” touches the umbo, and the umbo’s movements flex the material and produce an electrical charge through the piezoelectric effect. These electrical signals can then be processed and transmitted to the auditory nerve. “We’re using what nature gave us, which is the outer ear,” says Nakajima.

Why a cochlear implant needs low-noise, low-power electronics

Making a biocompatible microphone that can detect the eardrum’s minuscule movements isn’t easy, however. Jeff Lang, a professor of electrical engineering at MIT who jointly led the work, points out that only certain materials are tolerated by the human body. Another challenge is shielding the device from internal electronics to reduce noise. And then there’s long-term reliability. “We’d like an implant to last for decades,” says Lang.

In tests of the implantable microphone prototype, a laser beam measures the umbo’s motion, which gets transferred to the sensor tip. JEFF LANG & HEIDI NAKAJIMA

The researchers settled on a triangular design for the 3-by-3-millimeter sensor made from two layers of polyvinylidene fluoride (PVDF), a biocompatible piezoelectric polymer, sandwiched between layers of flexible, electrode-patterned polymer. When the cantilever tip bends, one PVDF layer produces a positive charge and the other produces a negative charge—taking the difference between the two cancels much of the noise. The triangular shape provides the most uniform stress distribution within the bending cantilever, maximizing the displacement it can undergo before it breaks. “The sensor can detect sounds below a quiet whisper,” says Lang.

Emma Wawrzynek, a graduate student at MIT, says that working with PVDF is tricky because it loses its piezoelectric properties at high temperatures, and most fabrication techniques involve heating the sample. “That’s a challenge especially for encapsulation,” which involves encasing the device in a protective layer so it can remain safely in the body, she says. The group had success by gradually depositing titanium and gold onto the PVDF while using a heat sink to cool it. That approach created a shielding layer that protects the charge-sensing electrodes from electromagnetic interference.

The other tool for improving a microphone’s performance is, of course, amplifying the signal. “On the electronics side, a low-noise amp is not necessarily a huge challenge to build if you’re willing to spend extra power,” says Lang. But, according to MIT graduate student John Zhang, cochlear implant manufacturers try to limit power for the entire device to 5 milliwatts, and just 1 mW for the microphone. “The trade-off between noise and power is hard to hit,” Zhang says. He and fellow student Aaron Yeiser developed a custom low-noise, low-power charge amplifier that outperformed commercially available options.

“Our goal was to perform better than or at least equal the performance of high-end capacitative external microphones,” says Nakajima. For leading external hearing-aid microphones, that means sensitivity down to a sound pressure level of 30 decibels—the equivalent of a whisper. In tests of the UmboMic on human cadavers, the researchers implanted the microphone and amplifier near the umbo, input sound through the ear canal, and measured what got sensed. Their device reached 30 decibels over the frequency range from 100 hertz to 6 kilohertz, which is the standard for cochlear implants and hearing aids and covers the frequencies of human speech. “But adding the outer ear’s filtering effects means we’re doing better [than traditional hearing aids], down to 10 dB, especially in speech frequencies,” says Nakajima.

Plenty of testing lies ahead, at the bench and on sheep before an eventual human trial. But if their UmboMic passes muster, the team hopes that it will help more than 1 million people worldwide go about their lives with a new sense of sound.

The work was published on 27 June in the Journal of Micromechanics and Microengineering.




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Crop Parasites Can Be Deterred by “Electric Fences”



Imagine you’re a baby cocoa plant, just unfurling your first tentative roots into the fertile, welcoming soil.

Somewhere nearby, a predator stirs. It has no ears to hear you, no eyes to see you. But it knows where you are, thanks in part to the weak electric field emitted by your roots.

It is microscopic, but it’s not alone. By the thousands, the creatures converge, slithering through the waterlogged soil, propelled by their flagella. If they reach you, they will use fungal-like hyphae to penetrate and devour you from the inside. They’re getting closer. You’re a plant. You have no legs. There’s no escape.

But just before they fall upon you, they hesitate. They seem confused. Then, en masse, they swarm off in a different direction, lured by a more attractive electric field. You are safe. And they will soon be dead.

If Eleonora Moratto and Giovanni Sena get their way, this is the future of crop pathogen control.

Many variables are involved in the global food crisis, but among the worst are the pests that devastate food crops, ruining up to 40 percent of their yield before they can be harvested. One of these—the little protist in the example above, an oomycete formally known as Phytophthora palmivorahas a US $1 billion appetite for economic staples like cocoa, palm, and rubber.

There is currently no chemical defense that can vanquish these creatures without poisoning the rest of the (often beneficial) organisms living in the soil. So Moratto, Sena, and their colleagues at Sena’s group at Imperial College London settled on a non-traditional approach: They exploited P. palmivora’s electric sense, which can be spoofed.

All plant roots that have been measured to date generate external ion flux, which translates into a very weak electric field. Decades of evidence suggests that this signal is an important target for predators’ navigation systems. However, it remains a matter of some debate how much their predators rely on plants’ electrical signatures to locate them, as opposed to chemical or mechanical information. Last year, Moratto and Sena’s group found that P. palmivora spores are attracted to the positive electrode of a cell generating current densities of 1 ampere per square meter. “The spores followed the electric field,” says Sena, suggesting that a similar mechanism helps them find natural bioelectric fields emitted by roots in the soil.

That got the researchers wondering: Might such an artificial electric field override the protists’ other sensory inputs, and scramble their compasses as they tried to use plant roots’ much weaker electrical output?

To test the idea, the researchers developed two ways to protect plant roots using a constant vertical electric field. They cultivated two common snacks for P. palmivoraa flowering plant related to cabbage and mustard, and a legume often used as a livestock feed plant—in tubes in a hydroponic solution.

Two electric-field configurations were tested: A “global” vertical field [left] and a field generated by two small nearby electrodes. The global field proved to be slightly more effective.Eleonora Moratto

In the first assay, the researchers sandwiched the plant roots between rows of electrodes above and below, which completely engulfed them in a “global” vertical field. For the second set, the field was generated using two small electrodes a short distance away from the plant, creating current densities on the order of 10 A/m2. Then they unleashed the protists.

With respect to the control group, both methods successfully diverted a significant portion of the predators away from the plant roots. They swarmed the positive electrode, where—since zoospores can’t survive for longer than about 2 to 3 hours without a host—they presumably starved to death. Or worse. Neil Gow, whose research presented some of the first evidence for zoospore electrosensing, has other theories about their fate. “Applied electrical fields generate toxic products and steep pH gradients near and around the electrodes due to the electrolysis of water,” he says. “The tropism towards the electrode might be followed by killing or immobilization due to the induced pH gradients.”

Not only did the technique prevent infestation, but some evidence indicates that it may also mitigate existing infections. The researchers published their results in August in Scientific Reports.

The global electric field was marginally more successful than the local. However, it would be harder to translate from lab conditions into a (literal) field trial in soil. The local electric field setup would be easy to replicate: “All you have to do is stick the little plug into the soil next to the crop you want to protect,” says Sena.

Moratto and Sena say this is a proof of concept that demonstrates a basis for a new, pesticide-free way to protect food crops. (Sena likens the technique to the decoys used by fighter jets to draw away incoming missiles by mimicking the signals of the original target.) They are now looking for funding to expand the project. The first step is testing the local setup in soil; the next is to test the approach on Phytophthora infestans, a meaner, scarier cousin of P. palmivora.

P. infestans attacks a more varied diet of crops—you may be familiar with its work during the Irish potato famine. The close genetic similarities imply another promising candidate for electrical pest control. This investigation, however, may require more funding. P. infestans research can be undertaken only under more stringent laboratory security protocols.

The work at Imperial ties into the broader—and somewhat charged—debate around electrostatic ecology; that is, the extent to which creatures including ticks make use of heretofore poorly understood electrical mechanisms to orient themselves and in other ways enhance their survival. “Most people still aren’t aware that naturally occurring electricity can play an ecological role,” says Sam England, a behavioral ecologist with Berlin’s Natural History Museum. “So I suspect that once these electrical phenomena become more well known and understood, they will inspire a greater number of practical applications like this one.”




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What My Daughter’s Harrowing Alaska Airlines Flight Taught Me About Healthcare

As a leader who has committed much of his career to improving healthcare — an industry that holds millions of people’s lives in its hands — I took from this terrifying incident a new guiding principle. Healthcare needs to pursue a zero-failure rate.

The post What My Daughter’s Harrowing Alaska Airlines Flight Taught Me About Healthcare appeared first on MedCity News.




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The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know

Building trust while simultaneously building products, selling, recruiting, and fundraising can feel impossible. But it’s required whether you have the time or not, and it doesn’t stop no matter how big you grow.

The post The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know appeared first on MedCity News.




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How One Massachusetts Maternal Mental Health Program Scaled Across the Country

During a recent panel, experts discussed the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and how it achieved scale.

The post How One Massachusetts Maternal Mental Health Program Scaled Across the Country appeared first on MedCity News.




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Relaxed Federal Regulations Amid Pandemic Can Help Jails Better Treat Opioid Use Disorder

Few correctional facilities in the United States have treatment programs for individuals with opioid use disorder (OUD), despite clear evidence that certain medications reduce the risk of overdose and death. Even in facilities where treatment is available, the COVID-19 pandemic has complicated efforts to provide such care.




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Pew Urges Federal Government to Prioritize Better Exchange of Health Data

The Pew Charitable Trusts sent comments Jan. 4 to the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) urging them to support the easy exchange of individuals’ health records through a pair of regulations.




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Despite COVID-19 Challenges Dental Therapy Had a Watershed 2020 and Is Poised to Grow

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.




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Tools to Boost Beneficial Bacteria Can Help Poultry Farms Fight Salmonella

Chicken products cause an estimated 1 in 7 of the nation’s human Salmonella illnesses each year, partly because the pathogen can easily contaminate the environments where birds are raised. To reduce the risk that contaminated meat will reach consumers, poultry companies need measures that control the bacterium on farms where chickens are bred and raised.




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Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading




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Sir Elton John overhauls diet after suffering health scare

Sir Elton John has overhauled his diet after suffering a health scare. The 77-year-old singer has made a concerted effort to control his blood sugar levels in recent times, after being diagnosed with type 2 diabetes in the early 2000s and battling a "severe eye infection" earlier this year. Elton said on Ruthie's Table 4 podcast: "I can have an apple, I can eat a bit of melon. As long as you're sensible about it, it doesn't shoot your blood sugar up. But what I crave is chocolate and ice cream — I can't have any ice cream." Despite this, Elton revealed that his dream meal would still be full of sugar-filled desserts. The award-winning star — who is married to filmmaker David Furnish — said: "If I had a death row meal, it wouldn't contain anything except sweets, because I can't eat them now. So, I'd have ice cream, doughnuts, apple pie, rhubarb crumble." Elton has dealt with various health issues over the years, including having surgery for prostate cancer and battling a "severe eye infection". The singer detailed his most-recent problem in an Instagram post in September.




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$10m up for grabs in next Toto draw after 3 draws with no winners

A grand prize of $10 million is up for grabs at the upcoming Toto draw on Thursday (Nov 14) at 9.30pm. The Group 1 prize money has snowballed over the past three draws after no Group 1 winners were picked. According to Singapore Pools' website, the prize started at $1.2 million on Nov 4 before snowballing to $2.9 million on Nov 7 and $6 million on Nov 11. The last draw on Monday yielded three Group 2 winners who won $215,010 each. Tomorrow's draw will be a cascade draw, meaning that the prize money will be split between the Group 2 winners in the event that no Group 1 winner is chosen. If there are no Group 2 winners, the prize will be split among the Group 3 winners, and so on. The last time a Group 1 prize snowballed above $10 million was during the October 21 draw where two lucky winners bagged over $6.6 million each.




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Social media magic: How a former chef became Bobby Saputra, the internet's favourite billionaire playboy

In July 2024, internet personality Bobby Saputra posted a video of himself living it up at what appeared to be the star-studded, ultra-lavish wedding of Radhika Merchant and Anant Ambani, the youngest child of Indian billionaire and Asia's richest man, Mukesh Ambani. The video featured clips of Saputra dancing, feasting and soaking up the "completely crazy" celebrations. He gushes in the voiceover: "It was like watching a Bollywood production." The video quickly went viral, racking up 6.6 million views on Instagram, 5.1 million on TikTok, and another 2.2 million on YouTube. Thousands left comments, including some celebrities who claimed they spotted him there. Except… he never set foot in the party. As it turns out, he had pieced together clips from a wedding he attended a few months prior — complete with him in full Indian attire, dancing with friends — and spliced in shots from the Ambani wedding that he found online. The result? Social media magic.




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Words Matter: The Effect of Moral Language on International Bargaining

When states use moral language in a dispute, they reduce the possibility of compromise. The possibility of military escalation, meanwhile, rises in response to moral language when states’ domestic audiences accuse their governments of hypocrisy for their willingness to compromise. The Falkland Islands/Islas Malvinas case explores the theory.




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After Sobers, Who? The Telegraph

In one of the first books I read, the writer had posed the question: ‘Who was the greatest all-rounder in the history of cricket?’, before providing this answer: ‘He was a left-arm bowler and a right-hand batsman, who was born in the village of Kirkheaton’. I now forget the title of the book, but remember [...]




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211557: Home Minister meets U.S.' Burns

During a 20-minute discussion of Pakistan, Chidambaram asked Burns to treat groups "aimed at India" in the same way we treated "the groups directed against Americans in Afghanistan."




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211549: Under Secretary Burns meets Indian Prime Minister Manmohan Singh

In a June 11 meeting, Prime Minister Singh assured Under Secretary Burns of his strong personal commitment to strengthening further India's ties to the United States.




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Terror threats keep me awake, Manmohan Singh told U.S. official



  • The India Cables

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148953: Boucher's meeting with Foreign Minister Qureshi

During a March 28 meeting with Assistant Secretary or South and Central Asian Affairs Boucher, Foreign Minister-designate Shah Mehmood Qureshi confirmed that the new government wanted to work with the U.S. to combat extremism, increase trade and extend cooperation with India and Afghanistan.




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226157: Pakistan accepted U.S. military role in counter-insurgency operations




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833: Pakistan, Islamic terror and HUA

Benazir Bhutto said she was picking up disturbing intelligence of the existence of religious madrassas and other institutions, including youth training camps which could be spawning terrorism.




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Benazir spoke of terror camps, bid to oust her




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248366: Scenesetter for Codel Kerry's visit to India

You will find an Indian government that is more committed than ever to building a durable and wide ranging USG-GOI relationship after Prime Minister Singh's Washington visit in November.




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66945: Pak-US ties not reflected in multi-lateral fora

Pakistan is one of a handful of countries (including India, Brazil, and South Africa) that routinely oppose the United States in multilateral debates despite strong bilateral ties to the U.S.




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190946: Interior Secretary provides terms of A.Q. Khan's modified detention

S.M. Zafar, Khan's prominent and highly respected lawyer, had pledged to the government that the meeting with the press would be Khan's "first and last" such encounter.




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41524: OFAC discusses WMD, terror financing with UAEG, banks

UAEG officials pledged their cooperation on cases of mutual interest, but Central Bank Governor Sultan Nasser al-Suweidi noted his frustration with the USG over the frozen assets of A.Q. Khan's daughter, Dina Khan.




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223755: Finance minister on Pakistan's budget woes, Tokyo pledges, and U.S. assistance

In a September 3 meeting with the Ambassador, Finance Minister Shaukat Tarin said the GOP had included $2 billion in Tokyo Pledges in its budget but was grappling with a shortfall in actual donor assistance.




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233602: Finance minister Tarin on budgets, CSF dollar fund, and Pakistan's improving economic outlook

Tarin requested that an additional $500 million of U.S. assistance flow through the GOP - in addition to the $174 million already committed - to bolster GOP credibility and allow the GOP to more adequately support its priorities.